Allergan and Gedeon Richter announced Tuesday that the FDA has approved the filing to expand the label for Vraylar (cariprazine) to include use in treating depressive episodes associated with bipolar I disorder in adults. According to the companies, the new indication "makes Vraylar the only dopamine and serotonin partial agonist to treat the full spectrum of bipolar I symptoms in manic, mixed and depressive episodes."
Approval was backed by data from the pivotal RGH-MD-53, RGH-MD-54 and RGH-MD-56 trials. In all three studies, the 1.5-mg dose of Vraylar significantly improved symptoms versus placebo in adults with bipolar I depression, while in RGH-MD-54, the 3-mg dose also demonstrated significance over placebo.
Commenting on the expanded approval, Mizuho analyst Irina Koffler stated "[Allergan] has a long legacy in depression. This is more just building on the strength that they already have." The analyst forecast sales of $683 million for Vraylar this year, with the figure projected to climb to nearly $1.4 billion by 2026 with the label expansion.
Meanwhile, David Nicholson, chief R&D officer at Allergan, noted that the company is also testing Vraylar in autism and as an add-on treatment for major depressive disorder.
Vraylar was previously cleared by the FDA for the acute treatment of manic or mixed episodes associated with bipolar I disorder and schizophrenia in adults, as well as for the maintenance treatment of schizophrenia. In 2017, the agency issued a refuse-to-file letter to Allergan regarding its application seeking approval of the once-daily atypical antipsychotic for treating negative symptoms in schizophrenia.
Sales of Vraylar, which Allergan markets in the US and Canada, jumped 70 percent year-on-year to $143.7 million in the first quarter.
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